MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC ALTERA HANDSET (NO COST); NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Dizziness (2194)

Event Date 04/03/2021

Event Type  Injury  

Event Description

Patient advised he experienced headaches and dizziness from pulmozyme.He went to the hospital on 4/3 for it, md aware, length of stay not reported.Pt was told pulmozyme was not the cause of dizziness and headaches at the hospital, these symptoms have not returned.No other information.Indication: cystic fibrosis, pneumonia due to pseudomonas.Reported to (b)(6) by: patient/ caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC
• MDR Report Key: 11648061
• MDR Text Key: 245128419
• Report Number: MW5100685
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR